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The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.

The Reichert Tono-Vera® Tonometer is a hand-held, battery powered instrument that utilizes rebound methodology to measure the intraocular pressure (IOP) of the eye. The tonometer propels a small, plastic-tipped measurement probe in a controlled manner against a patient's unanesthetized eye in order to calculate IOP. The device has a simple, four-button control system and an LCD that provides information to the operator and displays measurement results.

There are two Tono-Vera Tonometer models:
· Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and
• Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306.

Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory.

The Tono-Vera Tonometer utilizes a camera-based alignment system, called ActiView™ to improve alignment with the apex of the cornea and reduce measurement variability caused by operator technique. The measuring process starts automatically once alignment conditions are fulfilled.

The device has two measurement options: 3+ (Quick) Measurement Option and 6 Measurement Option. Both the 3+ (Quick) Measurement Option and 6 Measurement Option use the same calculation for the IOP result. The 3+ (Quick) Option can calculate a final IOP result with as few as three measurements. The 6 Measurement Option always uses six measurements to calculate the final IOP result.

The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system.

The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.

Here's an analysis of the acceptance criteria and the study proving the device meets it, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on demonstrating substantial equivalence to a predicate device (Icare Ic100) and meeting an industry standard (ANSI Z80.10-2014) for tonometry. Specific numerical acceptance criteria for a direct comparison study between the Tono-Vera Tonometer and the Goldmann Applanation Tonometer are not explicitly stated as a table within the document. However, the performance metrics reported against the predicate device give us an indication of the performance expected and validated.

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The Xcel 455 Slit Lamp is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

The Xcel 455 slit lamp is a general purpose examination instrument used in a wide range of eye care practices. Slit lamps are used for ophthalmic observation of the structures of the eye. By controlling the light source, nature of slit, and filters, physicians, optometrists, ophthalmologists and eye care technicians can observe various structures in the eye. The Xcel 455 can be used on any patient; there are no contraindications.

Ophthalmic slit lamp design has not changed in decades, and like most, including the predicate Xcel 255, the Xcel 455 slit lamp consists of two fundamental subsystems, the illumination source to illuminate the eye to be examined, and the microscope to enable the practitioner to view the structures of the eye under magnification.

The Xcel 455 uses a low voltage (6 Volt, 20 Watt) dimmable halogen lamp, and a selection of 4 color filters, or none, to illuminate the eye. The device uses a stereo microscope with 5 selections of magnification ranges, from 6.5x to 40x, to view the structure. There is a mount that allows other devices to attach in line with the optical path, such as a prism type contact tonometer.

Like the predicate Xcel 255 device, the Xcel 455 device uses a steel body and glass lenses. The scientific principle of all slit lamps is to project light onto a patient's eye, so that a doctor may view the eye and its structures through a microscope.

The document describes the Reichert Xcel 455 Slit Lamp, an AC-powered slit lamp biomicroscope intended for examining the anterior eye segment to aid in diagnosing diseases or trauma affecting its structural properties. The submission claims substantial equivalence to the Reichert Xcel 255 Slit Lamp (K063750).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list acceptance criteria in a quantitative table with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it states that the device was evaluated against several international standards and "passed" them.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The tests performed are engineering and safety standard compliance tests, not clinical performance studies involving a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as there was no test set involving patient data requiring expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as there was no test set involving patient data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a physical slit lamp, not an AI-powered diagnostic tool, and no MRMC study was mentioned. The determination of substantial equivalence was based on nonclinical performance data, and did not include clinical data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is an ophthalmic examination instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable as the studies conducted were engineering and safety compliance tests, not clinical performance studies. The "ground truth" for these tests would be the established specifications and requirements of the various IEC and ISO standards.

8. The sample size for the training set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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The Ocular Response Analyzer is intended to measure intra-ocular pressure of the eye and biomechanical response of the cornea.

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The provided text is a 510(k) clearance letter for the Ocular Response Analyzer (ORA). It confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

Critically, this document DOES NOT contain the acceptance criteria or a study proving the device meets those criteria.

510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring the submission of new clinical efficacy or performance studies with detailed acceptance criteria in the same way a PMA (Premarket Approval Application) would.

Therefore, I cannot extract the requested information from the provided text. The document states the "Indications for Use" but does not detail performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

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An optical coherence tomography system indicated for the in vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases.

The SOCT Copernicus is an AC-powered device containing illumination and viewing optics intended to examine the retina of the eye. The SOCT Copernicus consists of a main unit, which houses the optical system used for imaging the retina, the light source, and a power supply. In addition, both systems utilize a chin rest/forehead rest assembly for patient interface and a computer with software for data analysis / image processing.

Here's an analysis of the SOCT Copernicus device based on the provided 510(k) summary, detailing its acceptance criteria and the supporting studies:

Acceptance Criteria and Device Performance for SOCT Copernicus

The SOCT Copernicus is an Optical Coherence Tomography (OCT) system intended for in-vivo imaging and measurement of the retina as an aid in the diagnosis and management of retinal diseases. The device's acceptance criteria are implicitly derived from its comparison to a legally marketed predicate device (Carl Zeiss STRATUS OCT) and its demonstrated precision.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision Test:
  • Sample Size: 10 normal eyes and 10 pathological eyes.
  • Data Provenance: Not explicitly stated, but likely from a single study center given the description "structured study". It is prospective as operators were "unaware of patient pathology", suggesting a controlled, forward-looking data collection.
• Clinical Comparison:
  • Sample Size: 27 eyes from 21 patients.
  • Data Provenance: Prospective case series conducted at the Cleveland Clinic Cole Eye Institute (USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Precision Test: The ground truth for this test was the measurements taken by the device itself under different operating conditions. There's no mention of external human experts establishing a separate "ground truth" for these measurements. The "3 operators" involved were observing and potentially performing the scans, but their role was in data collection for precision, not adjudication of pathology.
• Clinical Comparison: The "ground truth" (or reference for comparison) in this study was the measurements obtained from the predicate device (Carl Zeiss Meditec Stratus™ Time Domain OCT). The study focused on comparing the measurements between the two devices, not on validating the absolute accuracy against a gold standard established by a panel of experts. The physicians performing the scans would implicitly be qualified, but their role in establishing a separate "ground truth" is not described as involving a consensus process.

4. Adjudication Method for the Test Set

• Precision Test: No explicit adjudication method is described. The "good agreement" was determined through statistical analysis of measurements, not by expert consensus on image interpretation.
• Clinical Comparison: No explicit adjudication method is described. The comparison was statistical, between measurements obtained from the two devices themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an imaging device (an OCT scanner), not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here. The studies focused on the device's technical precision and its equivalence to a predicate device in terms of measurement output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the studies describe a standalone performance evaluation of the device. The "SOCT Copernicus Precision Test" evaluated the device's inherent repeatability and reproducibility. The "SOCT Copernicus Clinical Comparison" evaluated its measurement capabilities in direct comparison to another device, without human interpretation of the images themselves being the primary endpoint, but rather the measurements derived from the images. While humans operate the device, the performance being assessed is the device's ability to produce consistent and comparable measurements.

7. The Type of Ground Truth Used

• Precision Test: The ground truth was the measurements taken by the device itself, with the goal of showing consistency between repeated measurements and different operators.
• Clinical Comparison: The ground truth for comparison was the measurements obtained from the predicate device (Carl Zeiss Meditec Stratus™ Time Domain OCT).

8. The Sample Size for the Training Set

No information about a "training set" is provided. This device is an imaging instrument (hardware and embedded software), not a machine learning or AI algorithm that typically requires a separate training set. The descriptions relate to validation/testing of the device's performance, not the training of a predictive model.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or applicable in the context of this device's validation, there is no information on how its ground truth would have been established.

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The Ocu-Film Tip Cover is intended to be used to protect the Tono-Pen transducer from dust and fluids, and helps protect patients from risk of cross-contamination.

Ocu-Film Tip Cover

The provided document is a 510(k) clearance letter from the FDA for a device called "Ocu-Film Tip Cover." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the Ocu-Film Tip Cover is substantially equivalent to legally marketed predicate devices and is intended to protect Tono-Pen transducers from dust and fluids, and to help protect patients from the risk of cross-contamination.

Therefore, I cannot provide the requested information because it is not present in the provided text.

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An AC-Powered slitlamp biomicroscope is intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

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The document provided is a 510(k) clearance letter from the FDA for a device called "Xcel 255 Slit Lamp". This type of document confirms that a new medical device is substantially equivalent to a legally marketed predicate device, rather than providing a detailed technical study or specific performance metrics.

Therefore, the input document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information on standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory clearance, indicating equivalence to an existing device, but does not detail the technical performance testing that would typically be described in a study report.

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A slitlamp biomicroscope is intended for use in eye examination of - the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

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The provided text is a 510(k) clearance letter from the FDA for a device called "PSL Portable Slit Lamp". It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter is a regulatory document confirming clearance, not a technical report detailing performance study results.

Therefore, I cannot provide the requested information from this document.

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ATP is intended to measure intra-ocular pressure and comeal thickness of the eye for the purpose of aiding in the diagnosis and monitoring of glaucoma.

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The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "ATP (Auto Non-Contact) Tonometer/Pachymeter)" and an "Indications for Use Form" for a diagnostic ultrasound.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample sizes and data provenance for the test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study
• Results of a standalone performance study
• Type of ground truth used
• Sample size for the training set
• Method for establishing ground truth for the training set

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The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called the "Ocular Response Analyzer (ORA)." This document primarily focuses on the regulatory clearance process, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain the detailed information necessary to describe acceptance criteria, a specific study proving those criteria were met, or any of the other requested information related to AI/algorithm performance, ground truth establishment, or sample sizes for testing and training datasets.

The 510(k) clearance process, as exemplified here, is about demonstrating substantial equivalence to a predicate device, not necessarily providing a de novo clinical study with specific performance metrics against pre-defined acceptance criteria in the manner typically required for novel AI/ML medical devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter. The letter confirms substantial equivalence but doesn't detail performance metrics against specific acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available in this document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable or mentioned for this type of device and clearance. This is more relevant for AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable or mentioned. The ORA is a physical device that measures properties of the eye.
7. The type of ground truth used: Not available in this document.
8. The sample size for the training set: Not applicable or mentioned, as this is not an AI/ML device in the context of the training sets typically discussed for such algorithms.
9. How the ground truth for the training set was established: Not applicable or mentioned.

The document states the device's Indications for Use: "The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma." This is the primary functional statement provided.

To obtain the information you're asking for, you would typically need to refer to the 510(k) Summary or the full 510(k) Submission for K032799, which would contain detailed information about the design verification and validation studies performed, including any performance data used to demonstrate substantial equivalence to the predicate device. These documents are often publicly available through the FDA's 510(k) database.

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